LIFESCREEN APNEA— 510(k) K042745

Name: FDA 510(k) clearance K042745
Creator: U.S. Food and Drug Administration
Published: 2005-01-19

Substantially Equivalent

Del Mar Reynolds Medical, Inc.

FDA 510(k) clearance K042745 for LIFESCREEN APNEA, Substantially Equivalent on 2005-01-19. Applicant: Del Mar Reynolds Medical, Inc.. Device class: 2.

Clearance details

Applicant: Del Mar Reynolds Medical, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2004-10-04
Decision date: 2005-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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